Summary

for people ages 18 years and up (full criteria)
at San Diego, California and other locations
study started
estimated completion:

Description

Summary

The primary objectives of this study are to evaluate the safety and tolerability vesatolimod (formerly GS-9620) at escalating, multiple doses in HIV-1 infected virologically suppressed adults on antiretroviral therapy (ART) and to evaluate the virologic effect of vesatolimod as measured by changes in plasma HIV-1 RNA.

Official Title

A Phase 1b, Randomized, Blinded, Placebo-Controlled Dose-Escalation Study of the Safety and Biological Activity of GS-9620 in HIV-1 Infected, Virologically Suppressed Adults

Keywords

HIV-1 Infection Vesatolimod ARV regimen

Eligibility

For people ages 18 years and up

Key Inclusion Criteria:

  • HIV-1 infection
  • Aged ≥ 18 years at Pre-baseline/Day -13
  • On antiretroviral (ARV) treatment for ≥ 12 consecutive months prior to Pre-Baseline/Day -13
  • The following agents are allowed as part of the current ARV regimen: NRTIs,raltegravir, dolutegravir, rilpivirine, and maraviroc
  • The following agents are NOT allowed as part of the current ARV regimen: HIV protease inhibitors (including low dose ritonavir), cobicistat-containing regimens, elvitegravir, efavirenz, etravirine, and nevirapine
  • A change in ARV regimen ≥ 45 days prior to baseline/Day 1 for reasons other than virologic failure (eg, tolerability, simplification, drug-drug interaction profile) is allowed
  • Plasma HIV-1 RNA < 50 copies/mL at screening
  • Documented plasma HIV-1 RNA levels < 50 copies/mL (according to the local assay being used) for ≥ 12 months preceding the screening visit (measured at least twice using a licensed assay with a lower limit of quantitation of at least 40 copies/mL)
  • Unconfirmed virologic elevations of ≥ 50 copies/mL (transient detectable viremia,or "blip") prior to screening are acceptable. (If the lower limit of detection of the local HIV-1 RNA assay is < 50 copies/mL, the plasma HIV-1 RNA level cannot exceed 50 copies/mL on two consecutive HIV-1 RNA tests)
  • If ART regimen is changed ≥ 60 days prior to Pre-Baseline/Day -13, plasma HIV-1 RNA <50 copies/mL at Pre-baseline/Day -13 visit is required
  • No documented history of resistance to any components of the current ARV regimen
  • Availability of a fully active alternative ARV regimen, in the opinion of the Investigator, in the event of discontinuation of the current ARV regimen with development of resistance.
  • Hgb ≥ 11.5 g/dL (males) or ≥ 11 g/dL (females)
  • White blood cells (WBC) ≥ 2,500 cells/μL
  • Platelets ≥ 125,000/mL
  • Absolute neutrophil count (ANC) ≥ 1000 cells/μL
  • CD4 count ≥ 300 cells/μL
  • Albumin ≥ 3.9 g/dL
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2 × upper limit of the normal range (ULN)
  • Estimated glomerular filtration rate ≥ 60 mL/min
  • No autoimmune disease

Key Exclusion Criteria:

  • Hepatitis B surface antigen (HBsAg) positive
  • Positive anti-HBs antibody and negative HBsAg results are acceptable
  • Hepatitis C antibody (HCVAb) positive
  • Positive anti-HCV antibody and negative HCV polymerase chain reaction (PCR)results are acceptable
  • Documented history of pre-ART CD4 nadir < 100 cells/µL
  • Unknown pre-ART CD4 nadir is acceptable
  • A new AIDS-defining condition diagnosed within 90 days prior to screening
  • Acute febrile illness within 35 days prior to pre-baseline/Day -13

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations

  • UCSD Antiviral Research Center (AVRC)
    San Diego California 92103 United States
  • Mills Clinical Research
    Los Angeles California 90069 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Gilead Sciences
ID
NCT02858401
Phase
Phase 1
Study Type
Interventional
Last Updated
May 2, 2018